AveXis expands world-leading gene therapy manufacturing capacity with purchase of advanced biologics therapy manufacturing campus in Longmont, Colorado
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- Category: Novartis
AveXis, a Novartis company, today announced it signed an agreement to purchase an advanced biologics therapy manufacturing campus in Longmont, Colorado, further expanding AveXis' production capacity as it prepares to launch Zolgensma® (onasemnogene abeparvovec-xioi[1]) an investigational gene therapy awaiting global regulatory approvals for the treatment of spinal muscular atrophy (SMA) Type 1 and for future gene therapy treatments in development.
Novartis receives FDA approval for Mayzent® (siponimod), the first oral drug to treat secondary progressive MS with active disease
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- Category: Novartis
Novartis today announced that the US Food and Drug Administration (FDA) has approved Mayzent® (siponimod) for the treatment of adults with relapsing forms of multiple sclerosis, including secondary progressive multiple sclerosis (SPMS) with active disease, relapsing remitting multiple sclerosis (RRMS) and clinically isolated syndrome (CIS)*.
Forxiga approved in Japan for type-1 diabetes
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- Category: AstraZeneca
The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Forxiga (dapagliflozin) as an oral adjunct treatment to insulin for adults with type-1 diabetes (T1D). The approval is based on data from the Phase III DEPICT clinical programme and a dedicated trial in Japanese patients (D1695C00001).
Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD
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- Category: Boehringer Ingelheim
Boehringer Ingelheim has filed for regulatory approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) with the FDA and EMA. Nintedanib as an anti-fibrotic medicine is already approved in more than 70 countries for the treatment of patients living with idiopathic pulmonary fibrosis (IPF).
Bayer reaches settlement to resolve Xarelto™ litigation
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- Category: Bayer
More than five years after the Xarelto™ litigation began, and with Bayer and Janssen Pharmaceuticals prevailing in all six cases that went to trial, the companies have reached an agreement in principle to settle in the amount of 775 million U.S. dollars.
Pfizer secures exclusive option to acquire gene therapy company Vivet Therapeutics
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- Category: Pfizer
PARIS & Vivet Therapeutics ("Vivet"), a privately held gene therapy biotech company dedicated to developing gene therapy treatments for inherited liver disorders with high unmet medical need, and Pfizer Inc. (NYSE: PFE) announced that Pfizer has acquired a 15% equity interest in Vivet and secured an exclusive option to acquire all outstanding shares.
Bayer is taking collaboration with health care start-ups to the next level
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- Category: Bayer
As a pioneer when it comes to collaborating with digital health start-ups, Bayer is now taking the next step. Instead of one-off startup programs, it is now focusing on collaborating in specific digital health focus areas, e.g. digital therapeutics, AI for drug discovery, and patient engagement platforms to name a few. To do this, Bayer is combining the G4A programs and concentrating on longer-term collaborations and investments.
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